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Heart FailureImagingCRTNCT01323686

Empiric Versus Imaging Guided Left Ventricular Lead Placement in Cardiac Resynchronization Therapy

A study testing Imaging guided optimal LV lead placement in people with Heart Failure, run by University of Aarhus at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure
What is being tested?
Imaging guided optimal LV lead placement
Could I receive a placebo?
No, everyone receives an active treatment
How many people
182 participants
Where
1 siteDenmark
Study dates
Apr 2011to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
  • ECG with QRS ≥ 120 milliseconds and left bundle branch block (LBBB) or paced QRS ≥ 180 milliseconds.
  • LV systolic dysfunction (Ejection Fraction ≤ 35%).
  • written informed consent.

Who cannot join

  • Expected lifetime < 6 months.
  • Recent myocardial infarction (< 3 months).
  • Pregnant or lactating.
  • Inadequate echocardiographic images for determination of site with latest mechanical activation
  • No written informed consent.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Cardiology, Aarhus University Hospital, Skejby

    Aarhus N, DK-8200

Other trials in Denmark

About this study

The aim of this study is to investigate if imaging guided optimal left ventricular (LV) lead placement improves the response rate to cardiac resynchronization therapy (CRT). Consecutive patients meeting the standard criteria for CRT are included in a prospective, double-blinded, randomized trial to LV lead positioning either 1) guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and visualization of cardiac venous anatomy (cardiac computed tomography (CT), venography) to target an epicardial vein at the site of latest mechanical activation without scar tissue or 2) using standard LV lead placement.

Conditions
Heart Failure
Being tested
Imaging guided optimal LV lead placement
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imaging guided optimal LV lead placementOther

    LV lead placement guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and CT to target a cardiac vein at the site of latest mechanical activation without scar tissue.

    Visualization of cardiac venous anatomy is performed using cardiac CT if not contraindicated by depressed renal function (estimated glomerular filtration rate <30 ml/min) or allergy to contrast media. In that case, a coronary venogram is used.

Study groups in NCT01323686
Study groupRoleWhat they receive
Imaging guided LV lead placementExperimentalNot described
Receives: Other: Imaging guided optimal LV lead placement
Empiric LV lead placementNo interventionLV lead placement using standard clinical routine.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with clinical response to CRT

    Response to CRT defined as a combination of survival, free of hospitalization for heart failure, and improved functional status. The primary endpoint is attained if the patient is registered for one of the following three events:

    1. Death from any cause.
    2. Hospitalization for heart failure.
    3. No improvement in New York Heart Association (NYHA) functional class and <10% improvement in 6-minutes hall walk at end of study period.

    Measured: 6 months after CRT implantation

Secondary outcomes (13)

  1. All cause mortality

    Measured: 6 months after CRT implantation

  2. Hospitalization for heart failure

    Measured: 6 months after CRT implantation

  3. Changes in NYHA functional class

    Measured: 6 months after CRT implantation

  4. Changes in 6-Minutes Hall Walk

    Measured: 6 months after CRT implantation

  5. Changes in Quality of Life

    Using Minnesota Living with Heart Failure questionnaire.

    Measured: 6 months after CRT implantation

  6. Changes in Biochemical marker of heart failure

    Nt-ProBNP

    Measured: 6 months after CRT implantation

  7. Changes in LV Ejection Fraction

    Measured: 6 months after CRT implantation

  8. Changes of LV end-diastolic volume

    Measured: 6 months after CRT implantation

  9. Changes of LV end-systolic volume

    Measured: 6 months after CRT implantation

  10. Changes of LV dyssynchrony

    Measured: 6 months after CRT implantation

  11. Changes of mitral regurgitation grade

    Measured: 6 months after CRT implantation

  12. Duration of CRT implantation

    Measured: During CRT implantation

  13. Complications

    Measured: 6 months after CRT implantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionApr 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
182 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323686
Sponsor's protocol ID
sksCRT
Acronym
ImagingCRT
Status last verified
Aug 2013
First submitted
25 Mar 2011
Last updated
5 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Fyenbo DB, Norgaard BL, Blanke P, Sommer A, Duchscherer J, Kalk K, Kronborg MB, Jensen JM, McVeigh ER, Delgado V, Leipsic J, Nielsen JC. Geometric Changes in Mitral Valve Apparatus during Long-term Cardiac Resynchronization Therapy as Assessed with Cardiac CT. Radiol Cardiothorac Imaging. 2024 Oct;6(5):e230320. doi: 10.1148/ryct.230320.

    PubMed 39360929

  • Sommer A, Kronborg MB, Poulsen SH, Bottcher M, Norgaard BL, Bouchelouche K, Mortensen PT, Gerdes C, Nielsen JC. Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial. Trials. 2013 Apr 26;14:113. doi: 10.1186/1745-6215-14-113.

    PubMed 23782792

Questions about this trial

What is this clinical trial studying?

A study testing Imaging guided optimal LV lead placement in people with Heart Failure, run by University of Aarhus at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with clinical response to CRT (time frame: 6 months after CRT implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01323686, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2014.

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